BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYS

    MDR report key: 1083323 · Received July 29, 2008

    Report

    Report Number
    1020279-2008-00227
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    May 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO MODERATE ARTHROFIBROSIS OF THE LEFT KNEE. THE SURGEON DOES NOT RELATE THIS CONDITION TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENASYS INSERT JWH SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R